Epididymal U.S Findings in Asthenozoospermic &Correlation With L.Carnitine Level

NCT05436080 | Unknown

• 1 other identifier: epididymal findindgs by u.s
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the epididymal findings by U.S and study its correlation with seminal parameters including L.carnitine level in infertile males

Conditions

Asthenozoospermia

Outcome Measures

Primary Outcomes (1)

• Evaluate the percentage of epididymal head echotexture in asthenozoospermic infertile male and study its correlation with seminal parameters and L.carnitine level

  The sample size calculation was performed using G.power 3.1.9.2 (Universitat Kiel, Germany). The sample size was calculated as total n ≥65 with an allocation ratio of 5:3 in cases and control groups based on the following considerations: 0.05 α error and 80% power of the study to demonstrate that the percentage of epididymal head echotexture heterogeneity is 60% in infertile men (the primary outcome) compared to 25% in healthy fertile men according to a previous study by (Lotti et al., 2021). 15 cases were added to overcome dropout. Therefore, 80 patients will be allocated as 30 cases in fertile group and 50 cases in infertile group. Lotti, F., Frizza, F., Balercia, G., Barbonetti, A., Behre, H. M., Calogero, A. E., et al. 2021. The European Academy of Andrology (EAA) ultrasound study on healthy, fertile men: Scrotal ultrasound reference ranges and associations with clinical, seminal, and biochemical characteristics. Andrology, 9, 559-576

  Baseline

Secondary Outcomes (1)

• Evaluate other epididymal ultrasongraphic findings and study its correlation with seminal parameters and L.carnitine level

  Baseline

Interventions

U/S DEVICE

Epididymal Ultrasongraphic Findings by Scrotal U/S

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: evaluate the epididymal findings by U.S and study its correlation with seminal parameters including L.carnitine level in infertile males.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Study participants: Patients will be chosen from those attending the outpatient clinic of department of Dermatology, Venereology and Andrology, Assuit University hospitals

You may qualify if:

• married male( 50 asthenzoospermic infertile male and 30 with normal semen male) Age from 18 to 55 years.

You may not qualify if:

• Extreme age
• Single
• Recent L carnitine intake
• Undesended testis
• Genetic cause of inferitility
• Patients with clinical Varicocele
• Azoospermic patients

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• Lotti F, Frizza F, Balercia G, Barbonetti A, Behre HM, Calogero AE, Cremers JF, Francavilla F, Isidori AM, Kliesch S, La Vignera S, Lenzi A, Marcou M, Pilatz A, Poolamets O, Punab M, Peraza Godoy MF, Rajmil O, Salvio G, Shaeer O, Weidner W, Maseroli E, Cipriani S, Baldi E, Degl'Innocenti S, Danza G, Caldini AL, Terreni A, Boni L, Krausz C, Maggi M. The European Academy of Andrology (EAA) ultrasound study on healthy, fertile men: Scrotal ultrasound reference ranges and associations with clinical, seminal, and biochemical characteristics. Andrology. 2021 Mar;9(2):559-576. doi: 10.1111/andr.12951. Epub 2021 Jan 19.

  PMID: 33244893 BACKGROUND

MeSH Terms

Conditions

Asthenozoospermia

Condition Hierarchy (Ancestors)

Infertility, Male; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Emad abdel rahiem taha

  Assiut University

  STUDY DIRECTOR

• Ahmed mahmoud el shibany

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

yasser mohamed

CONTACT

01555509202; taher2014mohamed@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 28, 2022
• Study Start: August 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 16, 2023

Record last verified: 2023-08